DAY 1 – November 16, 2015 7:15-8:10 Registration and Breakfast 8:10-8:25 Chair’s Welcome Address Mark Paxton CEO Rx-360 8:25-9:00 Opening Keynote: State of the Industry Address – What Can We Look Forward To?

The big picture: the state of the biotech industry Challenges in capacity planning, make-buy decisions, and supply chain management Challenges and opportunities new markets and economies offer Keeping up with a complex and rapidly changing world The future: what can we expect? What can we look forward to?

Patrick Yang Former EVP, Technical Operations Genentech 9:00-9:35 Biologics Supply Chain: Modeling Point and Systemic Risks

Debating the merits of nimble and flexible facilities versus manufacturing battleships Preparing your pilot plants and manufacturing facilities to move forward with Phase II-III approvals Forecasting requirements for optimizing manufacturing equipment, facilities, and partners to increase speed to market Achieving business goals to better manage times of product and economic uncertainty Putting theory into practice: Implementing key metrics to improve manufacturing flexibility

Andrew Skibo Head of Global Biologics Operations & Global Engineering AstraZeneca Biologics Lance Minor VP Global Biologics: Network Strategy & Performance AstraZeneca Biologics 9:40-10:15 9:40-10:15 9:40-10:15 CASE STUDY STREAM 1 CASE STUDY STREAM 2 CASE STUDY STREAM 3 STRATEGIC MANUFACTURING SUPPLY CHAIN MANAGEMENT QUALITY Assessing the Climate of Single-Use Technologies

Real-world examples of single-

use systems in industry and

Fill and Finish Supply Chain Management – Combining the Convenience of Local Manufacturing with the Security and Access of a Global Supply Chain

Why to plan your Fill & Finish

supply chain strategy earlier than later

How to balance the need for manufacturing resource efficiency

Creating a Clear Governance Model in your Organization to Successfully Implement New Processes and Quality Systems

What can manufacturing teams do

to enhance quality assurance and control?

Which attributes can quality teams bring to process engineering and design?

Managing manufacturing

comparability of product quality between single use and traditional processes

Financial considerations in choosing between single use vs. traditional (stainless steel) equipment

How do we manage the complexity without eliminating the flexibility and amenability for rapid response that are the benefits of single use systems?

How does industry work with suppliers to improve reliability and ensure visibility while also allowing for constant improvement?

Daniel Vellom Sr. Director, Global Technology Innovation Sanofi Pasteur Vijay Yabannavar Sr. VP, Manufacturing Ops. & Technical Development Emergent Biosolutions Alex Tschumakow Director Upstream Manufacturing Shire Jeff Ranney Director of Engineering Amgen

today with the need for an effective and secure global supply chain tomorrow

Practical frameworks to evaluate prospective fill & finish manufacturing partners

Carlos Villalobos VP Injectables and Biologics Actavis

complexity through: o Opening communication

lines in plant operations o Aligning strategic decision

making across the business o Improving governance

standards Allen Harmon Head of Quality Baxalta

10:15-11:30 Pre-Arranged One-to-One Meetings

10:20 am – 10:40 am: Meeting Slot 1/Networking 10:45 am – 11:05 am: Meeting Slot 2/Networking 11:10 am – 11:30 am: Meeting Slot 3/Networking

11:35-12:10 11:35-12:10 11:35-12:10 WORKSHOP WORKSHOP WORKSHOP STRATEGIC MANUFACTURING SUPPLY CHAIN MANAGEMENT QUALITY Transformation Simplified: Creating a Sustainable Culture of Connectivity, Clarity and Consistency

Identifying and revolutionizing

your organization’s benchmarking structure for enhanced performance, engagement, and response

Optimizing scorecards to educate, facilitate, and motivate: passive reports or active positioning devices?

Creating a communication cadence that drives focus, urgency, and accountability

Facility Scheduling and Data Integration

Operations and automation data –

what’s important, what’s not Optimization of facility,

maintenance and QC schedules Facility capacity analysis and

delivering product “on time” Understanding schedule

adherence and reconciliation

Gary Wright Sr. Account Director Bioproduction Group

Improving Biomanufacturing Operations and Plant Design through Single-Use Systems

What does the next generation

manufacturing plant look like? Enabling speed to market through

local manufacturing capacity Supporting manufacturing flexibility

across single-use systems Considering technologies to go from

campaign mode to parallel products in a ballroom concept

Parrish M. Galliher

Building a sustainable operating system through non-negotiable business processes

Leading your organization through a philosophy of accountability rather than dependency

Shane Yount Principal/Author Competitive Solutions, Inc

CTO Upstream and Founder Xcellerex Inc. GE Healthcare Life Sciences

12:15-12:50 12:15-12:50 12:15-12:50 CASE STUDY STREAM 1 CASE STUDY STREAM 2 CASE STUDY STREAM 3 STRATEGIC MANUFACTURING SUPPLY CHAIN MANAGEMENT QUALITY Strategies in Effective Tech Transfer

Establishing an error-proof

system in internal and external tech transfer

Right Actions at the Right Time operational excellence through documentation and business systems

Tech transfer evolution to risk-based control strategy

David Allen Sr. Dir. Manufacturing, Science & Technology Eli Lily & Company

Managing Supply Chain in an Outsourcing Model

Establishing strong operational

control and quality processes to drive supply chain transparency

Mitigating supply chain risk through the application of regulatory guidance from the FDA, EU, and ICH

Striking the balance between cost and security of materials manufacturing at suppliers and CMOs

Assessing internal and external contractor’s capabilities to build a culture of quality across complex global supply chains

Stephen Liebowitz Vice President, Technical Operations Shire

Quality Value Index: Informed Risk-Based Decisions for Quality

Usefulness in determining effective

utilization of resources Provides insights into whether we

are becoming more effective as a result of the sum of the continuous improvement projects being implemented YOY.

Ability to measure the aggregate impact of the Quality improvement efforts

Enables focus on prevention rather than failure

Janeen Skutnik‐Wilkinson PO&T Regulatory Intelligence Lead Biogen Idec

12:50-1:50 THEMED LUNCHES Themed lunches are roundtable discussions amongst industry leaders where you will have the opportunity to discuss the most pressing issues. Each roundtable will be lead by an expert in the field. Limited seating available. Select from:

Ensuring Quality Within CMO’s

Lucy Cabral Sr. Director Global Supplier Quality Roche

Manufacturing Complexities of Animal Health

Bernd Eichenmueller VP of US Operations-Vetmedica Boehringer Ingelheim Inc.

Engineering the Facility of the Future

Dave Steinberg Director of Engineering & Facilities Agensys

Human Error Reduction

Kathir Swamy Head of Product Quality Management Sanofi Pasteur

The Value of Continuous Processing in Biopharmaceutical Manufacturing

Jon Coffman Director of Bioprocess Engineering Boehringer Ingelheim Inc.

Tech Transfer – Quality, Cost & Speed – Solving For All Three

Nick Keener Director of Process Engineering and Process Validation Amgen

1:50-2:25 1:50-2:25 1:50-2:25 CASE STUDY STREAM 1 CASE STUDY STREAM 2 CASE STUDY STREAM 3

STRATEGIC MANUFACTURING SUPPLY CHAIN MANAGEMENT QUALITY Single-Use Technologies for Rapid and Flexible Manufacturing

Versatility to handle products

from microbial, mammalian, avian, and insect cell culture systems

Products ranging from vaccines to bio therapeutics, and proteins to live viral vectors

Standardization to allow rapid manufacturing to meet urgent demands

Optimal scale to derive the benefits from reduced capital expenditure and increased flexibility

Suitability for commercial and biodefense applications

Vijay Yabannavar SVP Manufacturing Operations & Technical Development Emergent BioSolutions

Design to Value: Building a Patient-Driven Lifecycle Management Process and Robust Manufacturing Processes

Discussing Janssen

Pharmaceutical’s approach to “Design to Value”

Building robust manufacturing processes to yield products that are more customer- or patient-centric over their lifecycle

Describing each aspect of the implementation strategy with practical examples

Offering lessons learned from Janssen’s experience and talking about what comes next

Remo Colarusso VP, Manufacturing & Technical Operations Johnson & Johnson

Technology Transfer to Fill/Finish CMO & Considerations for High-Value Biologic API

Designing and implementing a well-

planned fill/finish program Performing Due Diligence and

Process Risk Assessment to ensure your BDS/BDP design can be safely handled by a Fill/Finish CMO

Do you have adequate budget for BDS/BDP to thoroughly analze and characterize manufacturing sensitivities?

Offering best practices to communicate and collaborate with CMOs to eliminate risk and improve performance

Matt Dunlavy Production Manager

One 2 One™

2:30-3:05 2:30-3:05 2:30-3:05 WORKSHOP WORKSHOP WORKSHOP STRATEGIC MANUFACTURING SUPPLY CHAIN MANAGEMENT QUALITY Increasing Single-Use Facility Intelligence: The Advent of SMART Technologies

How the biopharma market is

changing and impact on facility planning

A “Smart” automation approach to increase facility utilization

How automation and integration with plan management will facilitate future processes

Barbara Paldus CEO/Co-Founder Finesse Solutions

Ensuring the Security of the Materials Within the Supply Chain

Investigating what dangers are

inherent in shipping between international markets

Exploring what options are available for safe and secure international transport of clinical and commercial product

Establishing how to ensure security in line with regulatory requirements as it relates to the GDP directive

James Klingelhoefer Regional Director World Courier

Developing Chromatography Technologies for Current and Future Bioprocessing

Innovation in resin design,

membrane chromatography and novel chromatographic supports

Accommodating future paths for disposable, continuous, single use or conventional batch bioprocessing

Disposable membrane chromatography and its utility for Mab production

Introducing Amspheretm A3, a best in class resin with capability for high productivity or high capacity driven processes

A peek at a novel chromatographic supported bed that can change chromatography operations as we know it today

Marty Siwak Director Separations Sciences Group JSR Life Sciences

3:10-4:25

Pre-Arranged One-to-One Meetings

3:15 pm – 3:35 pm: Meeting Slot 4/Networking 3:40 pm – 4:00 pm: Meeting Slot 5/Networking 4:05 pm – 4:25 pm: Meeting Slot 6/Networking

4:30-5:05 Managing Manufacturing Complexity

Ensuring business growth through smart planning, capital efficiency and talent development Case studies in managing trade offs and successful management execution Building quality into operations Using good science as a foundation Taking prudent risks and properly managing the product lifecycle

Andy Ramelmeier SVP, Biologics Technical Operations Portola Pharmaceuticals, Inc

5:05-5:40 Elevating the Healthcare Supply Chain to the Next Level of Performance

Are you sure you really understand the performance level of your supply chain? How do you ensure you are meeting your customer expectations? Ensuring the upstream and downstream supply chains are aligned Ensuring optimized network structure and flow Defining what end to end really means

Joerg Heidrich Bayer HealthCare SVP Global Product Supply

5:40-5:45

Chair’s Closing Remarks Mark Paxton CEO Rx-360 5:45 Drinks Reception

DAY 2 – November 17, 2015

8:00-8:35

Registration and Breakfast

8:35-8:40 Chair’s Welcome Address Mark Paxton CEO Rx-360 8:40-9:15 Leadership and Lean: Let’s Talk About You For a Minute

Understanding how your leadership impacts the day-to-day operations in your facilities:

o What are your true objectives? o Are you planning and communicating those goals to your team effectively?

Setting performance targets and timelines for the creation and sustainment of a continuous improvement culture Identifying what you need in terms of tools and culture change to achieve your objectives Using the soft skills of ‘people power’ to win hearts and minds Seeking out new ways to motivate and empower your team How does your role evolve as lean programming moves into a CI culture?

Tim Moore SVP, Global Head, Pharmaceutical Technical Operations Biologics Genentech 9:15-9:50 Can We Advance Technology in the Current Regulatory Environment? Operating in the Post-Approval Change Jungle

While the pharmaceutical industry is globalizing their business it looks like health authorities are nationalizing their processes

more. What can we do together to advance new technologies in our industry? Where did Process Analytical Technology (PAT) go? Has the innovation train lost steam due to too many hurdles? How can the Pharmaceutical Quality System be used effectively to reduce regulatory burden and enhance innovation?

Anders Vinther Chief Quality Officer Sanofi Pasteur 9:55-10:30 9:55-10:30 9:55-10:30 CASE STUDY STREAM 1 CASE STUDY STREAM 2 CASE STUDY STREAM 3

STRATEGIC MANUFACTURING SINGLE USE TECHNOLOGIES QUALITY

Economics of Biosimilars – Challenges in Bringing the Next Generation of Biosimilars to Market

Balance between innovation and

competition The potential entry into the US

market and the barriers to entry that exist

The European experience of biosimilars

Market opportunities and

Assessing the Latest Advances in Single-Use Bioreactor Control Strategies for Process Optimization

Overcoming challenges to scale-up,

process development and technical transfer from single-use or traditional bioreactors

Demonstrating dual sparger designs for more predictable process development and scale-up

Achieving a well-characterized

Harmonizing the Scientific and Technical Principles of ICH Q11

Moving from a traditional

approach to an enhanced approach for process development

How this progression aids in product lifecycle management and the development of a robust control strategy

Applying the concept of design space to your operations and its

competitive response Examining the future of the

Biologics Market Dr. Joseph Fuhr Professor of Economics Widener University

hydrodynamic environment Employing key scale-up

parameters: o Power input per unit

volume o Mixer tip speed o Oxygen transfer coefficient

Enhancing cell growth and productivity by balancing the need for CO2 stripping and O2 delivery

Christopher Stevens Director, Manufacturing Operations GSK

relationship to change management

Successfully submitting information from manufacturing process development in the CTD format

Peter Carbone VP, Global Head External Relations, Group Quality Novartis

10:30-11:10

Pre-Arranged One-to-One Meetings

10:35 am – 10:55 am: Meeting Slot 7/Networking 11:00 am – 11:20 am: Meeting Slot 8/Networking

11:25-12:00 11:25-12:00

CASE STUDY STREAM 1 CASE STUDY STREAM 3

STRATEGIC MANUFACTURING QUALITY

Generating Competitive Advantage and Improving Performance through Lean Biomanufacturing

Securing buy-in and input from both

management and the workforce Developing and applying lean

principles to your biomanufacturing operations

Using OpEx programming to drive quality and compliance performance

Correcting inefficiencies through coordinating internal and external manufacturing efforts

Taking the next step – evolving current standard operating procedures for continuous improvement

Maureen Skowronek VP Operations Biologics Merck & Co.

Implementing an Automated Environmental Monitoring Technology on the Manufacturing Floor

Streamlining the environmental

monitoring operation Reducing the transfer of materials

and equipment between the microbiology laboratory and the manufacturing facility

Improving environmental control with collaboration between manufacturing technicians and QC microbiology scientists

Reducing human error in environmental sampling and data collection

Business value proposition of technology implementation Amy McDaniel Technical Operations Director Pfizer, Inc.

12:05-12:40 12:05-12:40

WORKSHOP WORKSHOP

STRATEGIC MANUFACTURING SUPPLY CHAIN MANAGEMENT

Establishing an Effective Quality Focus to Improve Bioprocessing Operations

Bringing the Internet of Things to Life Sciences: Improving Visibility, Communication, and Collaboration Both Internally and Externally

Creating a quality focus early in the product lifecycle to ease the path to product realization and a state of control

Balancing phase appropriate applications of:

o Quality systems o Knowledge and risk

management o Product control

Practically embedding a quality focus into the product lifecycle Abel Hastings Director of Process Sciences FUJIFILM Diosynth Biotechnologies

How is the IoT movement changing the way biopharmaceutical manufacturers do business?

Showcasing Smart Factories that increase compliance, reduce cost and increase OEE through M2M communication

Improving visibility, traceability and compliance up and down the supply chain through new technologies

Avoiding the crush of Big Data through clear goals and an understanding of the real KPIs

Drawing the line that connects new capabilities to both the company’s superior performance and improved patient outcome Ibrahim Khalid Practice Advisor, Business Transformation – Life Sciences Cisco Systems

12:40-1:40

Lunch and Learn Roundtables Themed lunches are roundtable discussions amongst industry leaders where you will have the opportunity to discuss the most pressing issues. Each roundtable will be lead by an expert in the field. Limited seating available. Select from:

Rapid Microbiology Detection through On-Line Bioburden Analyzers

Leveraging the Power of Connected Intelligence

1:40-2:15

The War Against Fake Medicines – What You Need To Know

What are today’s current threats to our industry and our patients?

How is industry mobilizing around these threats to tighten our supply chains? What are regulators doing and how will this impact industry? What should you consider for your companies supply chain security program?

Mark Paxton CEO Rx-360 2:15-2:50

Strategies for Disruptive Process Development and Future Biologics Manufacturing

Trend of the biopharmaceutical industry and needs for affordable biologics worldwide Challenges and opportunities in current process development and biomanufacturing practices Disruptive biomanufacturing processes and systems enabling global supply of cost-effective and high quality biologics Strategic integration of relevant technologies from biotech and other industries Future manufacturing plant employing continuous bioprocesses for various biologics including biosimilars and cell therapies

Steven Lee Head, Biologics Technical Operations & CEO Singapore Operations Dr Reddys Labratories

2:50-3:35

Panel Discussion: Improving Quality and Communication Up and Down the Supply Chain

How can the commercial organization engage with manufacturing teams to better manage supply? Anticipating and mitigating variations in product quality and delivery times Building a robust two-way flow of information into multi-region transportation collaborations Ensuring supply and demand is balanced – key supply chain metrics

Edward Bjurstrom Vice President Operations Gilead Sciences

Diane Petitti VP, Head of Global Biologics Quality Bristol-Myers Squibb

Anthony Hurley VP, Head External Manufacturing Genentech

Matt Gray Director QA Systems Biomarin

James Klingelhoefer Regional Director World Courier

Gary Barrera Head of Quality Theravance Biopharma

3:35-3:40

Chair’s closing address Mark Paxton CEO Rx-360